Congress Addresses Medical Device Innovation

As a preliminary to the US Energy and Commerce Committee’s Subcommittee on Health, the House Committee Chariman, Fred Upton (R) Michigan and Congresswoman Diana DiGette (D) Colorado announced the committee’s healthcare innovation strategies.

With a goal of America as the “healthcare innovation capitol of the world,” the committee is focused on the federal drug and device approval apparatus.

Edwards Lifesciences Chairman and CEO Michael A. Mussallem served as an expert panelist at the invitation of the Subcommittee.

Mussallem noted the constructive and collaborative relationship with the Food and Drug Administration and the Centers for Medicare & Medicaid Services and identified three primary areas of improvement to promote America’s leadership in medical device development, and ensure delivery of new treatments to patients around the world:

• Evidence development mechanisms can be improved to reduce costs and delays.
• Economic incentives need to be aligned with promoting innovation.
• FDA’s vision to improve the regulatory process must be accelerated.

Mussallem drew on Edwards’ experience with the SAPIEN transcatheter aortic heart valves to discuss the regulatory and reimbursement challenges and opportunities in the U.S.

The lineup of witnesses include:

Healthcare Leadership Council

Mary Grealy, President

 

Edwards Lifesciences

Michael A. Mussallem, Chairman and CEO

 

Carolina Arthritis Associates, On Behalf of the Alliance for Specialty Medicine

Gregory Schimizzi M.D., Cofounder

 

The Pew Charitable Trusts

Josh Rising, MD, MPH, Director, Medical Devices

 

ADVI

Louis Jacques, Senior Vice President and Chief Clinical Officer

 

By: Dan Charobee, MBA